FDA UDI
In Commercial Distribution
🇺🇸 United States
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW
DI: 07630031702869
·
Model: 1
·
Institut Straumann AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW
- Primary DI
- 07630031702869
- Version / Model
- 1
- Catalog Number
- 010.1156
- Company Name
- Institut Straumann AG
- Labeler DUNS
- 483599259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 7b2c697b-6157-4658-81bf-13c5788085f5
Device Description
CARES® Milled Bar, 9 Implants, Ti/TAN
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38614 | Dental bridge, metal-ceramic | A custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630031702869 | GS1 |
Customer Contacts
- Phone
- +1(800)448-8168
- [email protected]